Mektovi 15 mg film-coated tablets

DRUG10 trials

Sponsors

Asociacion Grupo Tratamiento De Tumores Digestivos, Unicancer, Unicancer, European Organisation For Research And Treatment Of Cancer, Unicancer, Pfizer Inc.

Conditions

Advanced Biliary Cancer (ABC)BRAF V600 mutation–positive unresectable or metastatic melanomaBRAF V600E mutated and microsatellite stable (MSS) advanced colorectal cancer (aCRC) initially resectable or potentially resectableBRAF(V600) mutation-positive melanoma with brain metastasis (MBM)BRAFV600E-mutant metastatic Non-small Cell Lung CancerColorectal cancerMelanomaNon-small Cell Lung Cancer

Phase 1

A dose-esalation phase I/II study in patients with RAS-mutated metastatic colorectal cancer to investigate safety and clinical actvitiy of the triple combination of: MEK-inhibitor binimetinib, pan-EGFR inhibitor lapatinib and the microtubule targeting agent (MTA) vinorelbine (RASTRIC)

CompletedCTIS2023-509732-25-00

Universitair Medisch Centrum Utrechtmetastatic colorectal cancer with a proven RAS mutation after failure of standard systemic treatment regimens including at least 5- FU/capecitabine-oxaliplatin and irinotecan based standard treatment (unless contra-indications for either oxaliplatin or irinotecan)

Start: 2020-07-31End: 2025-02-17Target: 50Updated: 2024-09-10

Phase 2

Multicenter Phase 2 study to evaluate the efficacy and safety of Cetuximab in combination with Encorafenib plus Binimetinib as induction treatment in BRAF V600E mutated MSS initially resectable or potentially resectable advanced colorectal cancer.

RecruitingCTIS2022-502413-29-00

Asociacion Grupo Tratamiento De Tumores DigestivosBRAF V600E mutated and microsatellite stable (MSS) advanced colorectal cancer (aCRC) initially resectable or potentially resectable

Start: 2024-01-22Target: 70Updated: 2024-10-30

BEPCOME-MB: Phase 2, randomised trial testing the addition of upfront stereotactic radiosurgery to binimetinib, encorafenib plus pembrolizumab in comparison with binimetinib, encorafenib plus pembrolizumab alone in patients with BRAFV600 mutationpositive melanoma with brain metastasis

Active, not recruitingCTIS2023-505302-42-00

Unicancer, UnicancerBRAF(V600) mutation-positive melanoma with brain metastasis (MBM)

Start: 2022-09-05Target: 150Updated: 2025-04-07

An open-label single arm interventional phase 2 study to investigate outcome of individualized treatment based on pharmacogenomic profiling and ex vivo drug sensitivity testing of patient-derived organoids in patients with metastatic colorectal cancer

RecruitingCTIS2023-510092-62-00

Oslo University Hospital HFColorectal cancer

Start: 2022-09-27Target: 45Updated: 2025-06-26

EORTC 1612-MG: Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation: an EORTC randomized phase II study (EBIN)

Active, not recruitingCTIS2023-505376-30-00

European Organisation For Research And Treatment Of CancerBRAF V600 mutation–positive unresectable or metastatic melanoma

Start: 2018-10-30Target: 264Updated: 2026-01-22

C4221008 - A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Non-small Cell Lung Cancer

CompletedCTIS2024-515929-28-00

Pfizer Inc.Non-small Cell Lung Cancer

Start: 2019-08-02End: 2025-08-14Target: 59Updated: 2025-08-19

IFCT-1904 ENCO-BRAF A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer

Active, not recruitingCTIS2024-515944-22-00

Intergroupe Francophone De Cancerologie ThoraciqueBRAFV600E-mutant metastatic Non-small Cell Lung Cancer

Start: 2021-01-19Target: 119Updated: 2024-10-31

Phase II, single arm, multicentre clinical trial to evaluate the activity of encorafenib plus binimetinib followed by Cemiplimab And Fianlimab in patients with BRAF mutated melanoma and symptomatic brain metastases.

RecruitingCTIS2024-513375-40-00

Grupo Espanol Multidisciplinar De MelanomaMelanoma

Start: 2025-05-16Target: 33Updated: 2025-11-25

Phase 3

SAFIR ABC10 : Molecular targeted maintenance therapy versus standard of care in advanced biliary cancer: an international, randomised, controlled, open-label, platform phase 3 trial

RecruitingCTIS2023-508100-38-00

UnicancerAdvanced Biliary Cancer (ABC)

Start: 2024-06-24Target: 450Updated: 2025-05-14

Phase 4

C4221026: ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES

Active, not recruitingCTIS2023-509408-13-00

Pfizer Inc.Solid tumors

Start: 2022-09-20Target: 46Updated: 2025-08-11